Trial of Topical Verapamil in Chronic Rhinosinusitis With Nasal Polyps

NCT03102190 on ClinicalTrials.gov Phase 1 Benjamin Bleier (academic or other) Started 2017-06-05 Terminated

Riskier than 75% of active trials

Model scores of the 29,894 trials active now.

Model score 21% for any early termination, 9% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 6% of the time (340 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Terminated on 2018-03-26, after 2017-06-05 start.

Reason given by the sponsor: “business”

The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.

Termination over time, as the model saw it at the start

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2018-03-26. The rest of the way to 100% is still running.

From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.

What moved the score

Sponsor's past termination rate: 100% (raises risk) · Sponsor's track record
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: chronicpostatrialheartfailure
Phrases that lowered it: patientsevaluate theefficacyto evaluatecompleted
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 1 (lowers risk) · Design
Has a data monitoring committee: Yes (raises risk) · Design
Drug's FAERS reports with a death: 15.9% (lowers risk) · Drug's FDA history
Sponsor type: academic or other (raises risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Minimum age: 18 (raises risk) · Who can join
Disease area, respiratory: Yes (raises risk) · Disease area
Primary purpose: treatment (raises risk) · Design
Responsible party: sponsor investigator (raises risk) · Design
Sponsor's past trials: 1 (lowers risk) · Sponsor's track record
Number of arms: 1 (raises risk) · Design
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
Drug's FAERS reports marked serious: 71.3% (lowers risk) · Drug's FDA history
Collaborators: 0 (raises risk) · Design

Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.

The trial

Design

Phase: 1 (typical: 2)
Number of arms: 1 (typical: 2)
Allocation: not given (typical: randomized)
Design: sequential (typical: parallel)
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: sponsor investigator (typical: sponsor)
Collaborators: 0
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 80 (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: academic or other
Sponsor's past trials: 1 (typical: 32)
Sponsor's past termination rate: 100% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 0 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 1
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 22924 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 3102 (typical: 412.5)
Drug's FAERS reports marked serious: 71.3% (typical: 85.6%)
Drug's FAERS reports with a death: 15.9%

Disease area and drugs

Disease areas: infectious disease, respiratory
Drugs matched to FDA substances: verapamil

Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.

Similar finished trials

A Study to Investigate the Efficacy and Safety of Verekitug (UPB-101) in Participants With Chronic Rhinosinusitis With Nasal Polyps NCT06164704 · started 2023 · scored riskier than 8% of active trials completed
Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for the Acute Treatment of Chronic Rhinosinusitis NCT05248997 · started 2022 · scored riskier than 17% of active trials completed
Subcutaneously CM310/Placebo in Patients With Chronic Rhinosinusitis With Nasal Polyposis (CROWNS-1) NCT04805398 · started 2021 · scored riskier than 12% of active trials completed
A Study of CM326 in Patients With Chronic Rhinosinusitis With Nasal Polyps NCT05324137 · started 2022 · scored riskier than 7% of active trials completed
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 282 in Healthy Subjects and Subjects With Chronic Rhinosinusitis With Nasal Polyps NCT02170337 · started 2014 · scored riskier than 9% of active trials completed

Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.